Daiichi Sankyo’s Enhertu approved in Japan as treatment for metastatic NSCLC

Betsy Goodfellow | August 23, 2023 | News story | Medical Communications Daiichi Sankyo, Enhertu, Japan's MHLW, NSCLC, Oncology, trastuzumab deruxtecan 

Daiichi Sankyo has announced that Enhertu (trastuzumab deruxtecan) has been approved in Japan for the treatment of adult patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations that has progressed following treatment with chemotherapy.

The drug’s approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) follows results from the DESTINY-Lung02 phase 2 trial data which was shared at the European Society for Medical Oncology (ESMO) 2022 Congress. Throughout this trial the drug demonstrated a confirmed objective response rate (ORR) of 53.8%. The drug was previously granted Orphan Drug Designation by the MHLW for this indication.

The safety profile of Enhertu remained consistent with previous trials, with the most common adverse events being nausea, decreased neutrophil count, anaemia, decreased appetite, fatigue, constipation, decreased leukocyte count and vomiting.

Wataru Takasaki, PhD, executive officer and head of Daiichi Sankyo’s R&D Division in Japan, commented: “HER2 mutant non-small cell lung cancer is a rare but serious disease and now patients and physicians in Japan have the potential to benefit from the first HER2 directed treatment option approved specifically for this type of lung cancer. This is the fourth indication secured for ENHERTU in Japan in just over three years and the second approval this year alone, underscoring the benefit of this medicine across a range of HER2 targetable cancers.”

Betsy Goodfellow

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